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Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndromes, Non-Small Cell Lung Cancer, or Mesothelioma

Brief Summary

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill cancer cells. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop cancer cells from growing. Giving vaccine therapy together with GM-CSF may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects of vaccine therapy and GM-CSF in treating patients with acute myeloid leukemia, myelodysplastic syndromes, non-small cell lung cancer, or mesothelioma.

Tracking Information
First Received DateNovember 9, 2006
Last Changed DateFebruary 2, 2016
Start DateOctober 2006
Actual Primary Completion DateJune 2009
Primary Outcome Measures

Safety [Time Frame: 2 years]

Immune Response [Time Frame: 2 years]

Descriptive Information
PhasePhase 1
Study TypeInterventional
Condition
  • Leukemia
  • Lung Cancer
  • Malignant Mesothelioma
  • Myelodysplastic Syndromes
  • Primary Peritoneal Cavity Cancer
Intervention
  • Biological: WT-1 analog peptide vaccine
  • Biological: incomplete Freund's adjuvant
  • Biological: sargramostim
  • Genetic: polymerase chain reaction
  • Other: flow cytometry
  • Other: immunoenzyme technique
Study Arms / Comparison Groups1 / 0
Detailed Description

OBJECTIVES:

Primary

- Determine the safety and immunogenicity of the Wilms tumor-1 analog peptide vaccine in patients with acute myeloid leukemia, myelodysplastic syndromes, non-small cell lung cancer, or mesothelioma.

Secondary

- Determine the antitumor effects of this vaccine in these patients.

OUTLINE: This is a pilot study. Patients are stratified according to disease type (acute myeloid leukemia [AML] or myelodysplastic syndromes [MDS] vs non-small cell lung cancer or mesothelioma).

Patients receive vaccine comprising Wilms-tumor 1 (WT-1) analog peptide emulsified in Montanide ISA-51 subcutaneously (SC) once in weeks 0, 4, 6, 8, 10, and 12 and sargramostim (GM-CSF) SC twice in weeks 0, 4, 6, 8, 10, and 12 (on the day of and 2 days prior to each vaccination). Patients who have an immunologic response and have no disease progression may receive up to 6 more vaccinations approximately 1 month apart.

Blood samples are collected at baseline, week 8, and week 14. Samples are examined by polymerase chain reaction (PCR) to measure levels of WT-1 and by T-cell proliferative response, delayed-type hypersensitivity against WT-1 peptides, or ELISPOT to measure immune response.

Bone marrow samples are collected from patients with AML or MDS at baseline and week 14. Samples are examined by PCR to measure levels of WT-1 and by multiparameter flow cytometry to measure residual disease.

Recruitment Information
Recruitment StatusCompleted
Actual Enrollment22
GenderAll
Ages18 Years - 120 Years
Accepts Healthy VolunteersNo
Eligibility Criteria

DISEASE CHARACTERISTICS:

- Cytologically or histologically confirmed diagnosis of 1 of the following:

- Acute myeloid leukemia, meeting the following criteria:

- Documented Wilms tumor-1 (WT-1)-positive disease demonstrated by WT-1 protein on a pretreatment bone marrow biopsy OR detectable disease with real-time quantitative reverse transcriptase-polymerase chain reaction (RQ-PCR)

- Completed induction chemotherapy, achieved clinical remission, and completed postremission therapy OR achieved clinical remission and have no plans for further postremission chemotherapy (≥ 65 years of age)

- Myelodysplastic syndromes, meeting the following criteria:

- Documented WT-1-positive disease demonstrated by WT-1 protein on a pretreatment bone marrow biopsy OR detectable disease by RQ-PCR

- International Prognostic Scoring System (IPSS) score of ≥ Int-2

- Not a candidate for cytotoxic chemotherapy

- Non-small cell lung cancer, meeting the following criteria:

- Positive tumor staining for WT-1 in > 10% of cells

- Stage III or IV disease

- Completed chemotherapy, surgery, and/or radiotherapy

- Mesothelioma, meeting the following criteria:

- Positive tumor staining for WT-1 in > 10% of cells

- Unresectable or relapsed disease

- Chemo-naive or received 1 prior chemotherapy regimen

- Malignant pleural mesothelioma or peritoneal mesothelioma

- No leptomeningeal disease

- No CNS involvement

PATIENT CHARACTERISTICS:

- Karnofsky performance status 70-100%

- Absolute neutrophil count ≥ 1,000/mm³

- Platelet count > 50,000/mm³ (except for myelodysplastic syndromes where parameter is > 20,000/mm³ and not transfusion dependent)

- Bilirubin ≤ 2.0 mg/dL

- AST and ALT ≤ 2.5 times upper limit of normal

- Creatinine ≤ 2.0 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active infection requiring systemic antibiotics, antiviral, or antifungal treatments

- No serious unstable medical illness

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- At least 4 weeks since prior chemotherapy or radiotherapy

- No concurrent systemic corticosteroids

Administrative Information
NCTIDNCT00398138
Responsible Party,
SponsorMemorial Sloan Kettering Cancer Center
Verification DateFebruary 2016
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